Implant Delivery and Deployment System and Method

ABSTRACT

An implant delivery system comprising a catheter including at least one lumen, an implant configured for receipt in the lumen, and a latching mechanism configured for receipt in the implant. The latching mechanism may be configured to releasably couple the implant to a delivery wire and to transmit torque through the delivery wire to cause at least a portion of the implant to rotate. The an implant may comprise a shaft, a spacer configured to interact with at least a portion of at least one cusp of a heart valve to at least partially restrict a flow of blood through the heart valve in a closed position, a garage configured to couple the spacer to a first end region of the shaft, and at least one anchor mechanism. The garage may define a cavity to receive the latching mechanism and to increase rotational and translational stability of the latching mechanism.

CROSS REFERENCE TO RELATED APPLICATIONS

The subject application is a continuation of U.S. patent applicationSer. No. 12/431,399, now U.S. Pat. No. 8,216,302, filed Apr. 28, 2012which is a continuation-in-part of co-pending U.S. patent applicationSer. No. 11/258,828, now U.S. Pat. No. 8,092,525 filed on Oct. 26, 2005,U.S. patent application Ser. No.: 11/940,694, filed Nov. 15, 2007, andU.S. patent application Ser. No. 12/209,686, filed Sep. 12, 2008, theentire disclosures of which are incorporated herein by reference

FIELD

The present disclosure relates to the repair and/or correction ofdysfunctional heart valves, and more particularly pertains to heartvalve implants and systems and methods for delivery and implementationof the same.

BACKGROUND

A human heart has four chambers, the left and right atrium and the leftand right ventricles. The chambers of the heart alternately expand andcontract to pump blood through the vessels of the body. The cycle of theheart includes the simultaneous contraction of the left and right atria,passing blood from the atria to the left and right ventricles. The leftand right ventricles then simultaneously contract forcing blood from theheart and through the vessels of the body. In addition to the fourchambers, the heart also includes a check valve at the upstream end ofeach chamber to ensure that blood flows in the correct direction throughthe body as the heart chambers expand and contract. These valves maybecome damaged, or otherwise fail to function properly, resulting intheir inability to properly close when the downstream chamber contracts.Failure of the valves to properly close may allow blood to flow backwardthrough the valve resulting in decreased blood flow and lower bloodpressure.

Mitral regurgitation is a common variety of heart valve dysfunction orinsufficiency. Mitral regurgitation occurs when the mitral valveseparating the left coronary atrium and the left ventricle fails toproperly close. As a result, upon contraction of the left ventricleblood may leak or flow from the left ventricle back into the leftatrium, rather than being forced through the aorta. Any disorder thatweakens or damages the mitral valve can prevent it from closingproperly, thereby causing leakage or regurgitation. Mitral regurgitationis considered to be chronic when the condition persists rather thanoccurring for only a short period of time.

Regardless of the cause, mitral regurgitation may result in a decreasein blood flow through the body (cardiac output). Correction of mitralregurgitation typically requires surgical intervention. Surgical valverepair or replacement is carried out as an open heart procedure. Therepair or replacement surgery may last in the range of about three tofive hours, and is carried out with the patient under generalanesthesia. The nature of the surgical procedure requires the patient tobe placed on a heart-lung machine. Because of theseverity/complexity/danger associated with open heart surgicalprocedures, corrective surgery for mitral regurgitation is typically notrecommended until the patient's ejection fraction drops below 60% and/orthe left ventricle is larger than 45 mm at rest.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantage of the claimed subject matter will be apparentfrom the following description of embodiments consistent therewith,which description should be considered in conjunction with theaccompanying drawings, wherein:

FIG. 1 is a perspective view of one embodiment of a mitral valve implantdelivery system consistent with the present disclosure;

FIG. 2 depicts a plan view of one embodiment of an implant consistentwith the present disclosure;

FIG. 3 depicts a cross-sectional view of one embodiment of an implantillustrated in FIG. 2 consistent with the present disclosure;

FIG. 4 depicts an explode, cross-sectional view of the implantillustrated in FIG. 3 consistent with the present disclosure;

FIG. 5 depicts one embodiment of a latching mechanism comprising a firstand second latching pin in a decoupled position consistent with thepresent disclosure;

FIG. 6 depicts one embodiment of a latching mechanism comprising a firstand second latching pin in a coupled position consistent with thepresent disclosure;

FIG. 7 depicts a partial view of one embodiment of an implant andlatching mechanism with the anchoring mechanism in a retracted positionconsistent with the present disclosure;

FIG. 8 depicts a partial view of one embodiment of an implant andlatching mechanism with the anchoring mechanism in an extended positionconsistent with the present disclosure;

FIG. 9 depicts one embodiment of a loading sheath consistent with thepresent disclosure;

FIG. 10 depicts a cross-sectional view of one embodiment of an implant,a pusher and loading sheath consistent with the present disclosure;

FIGS. 11-14 illustrate one embodiment of loading an implant into adelivery catheter consistent with the present disclosure;

FIG. 15 depicts a schematic diagram illustrating one embodiment of theimplant de-airing procedure consistent with the present disclosure;

FIG. 16 depicts a schematic diagram illustrating one embodiment of thede-airing driver handle system consistent with the present disclosure;and

FIGS. 17-22 illustrate one embodiment for delivering an implantconsistent with the present disclosure.

DESCRIPTION

Referring to FIG. 1, a perspective view of one embodiment of apercutaneous delivery system 1 for delivering and/or recapturing amitral valve implant 10 within the heart is shown. The delivery system 1may include a mitral valve implant 10, a delivery catheter 12, aguidewire 14 and a deployment/clamping mechanism 16 configured toreleasably couple the implant 10 to a delivery wire (not shown). Theimplant 10 may comprise a spacer 18, a shaft or stop tube 20 and ananchoring mechanism 22. In general, the mitral valve implant 10 may bedelivered within the heart 1 and anchored to the native coronary tissue6 as generally illustrated in FIG. 1 such that at least a portion of thespacer 18 is disposed proximate a mitral valve 3 and the mitral valveimplant 10 may interact and/or cooperate with at least a portion of thenative mitral valve 3 to reduce and/or eliminate excessiveregurgitation, for example, as discussed in U.S. patent application Ser.No. 12/209,686, filed on Sep. 12, 2008 and entitled SYSTEM AND METHODFOR IMPLANTING A HEART IMPLANT, the entire disclosure of which isincorporated herein by reference. For example, at least a portion of oneor more cusps 4 of the heart 1 valve may interact with, engage, and/orseal against at least a portion of the heart valve implant 10 (forexample, but not limited to, the spacer 18) when the heart valve 3 is ina closed condition. The interaction, engagement and/or sealing betweenat least a portion of at least one cusp 4 and at least a portion of theheart valve implant 10 may reduce and/or eliminate regurgitation in aheart valve 3, for example, providing insufficient sealing, includingonly a single cusp 4, e.g., following removal of a diseased and/ordamaged cusp 4, and/or having a ruptured cordae. A heart valve implant10 consistent with the present disclosure may be used in connection withvarious additional and/or alternative defects and/or deficiencies.

As shown, the delivery system 1 may include a delivery catheter 12 (forexample, but not limited to, a steerable delivery catheter) configuredto be percutaneously introduced or inserted into one or more vessels ofthe body (e.g., one or more veins and/or arteries) and conveyed to theheart 1 for delivery and/or recapture of the mitral valve implant 10.Conveyance of the catheter 12 and/or of the mitral valve implant 10 tothe heart 1 may be directed and/or assisted by monitoring the travel ofthe catheter 12, e.g., via radiographic and/or other imaging techniquesand/or by passing the catheter 12 through another, larger catheteralready in place (not shown). The catheter 12 may have a length andouter diameter configured to extend from the incision site in thepatient's body through one or more veins and/or arteries to the desiredlocation within the heart 1 (e.g., the left ventricle 5).

The catheter 12 may define at least one lumen 24 having an internaldiameter configured to receive and convey the guidewire 14, thedeployment mechanism 16 and the implant 10 from a proximal end of thecatheter 12 to a distal end of the catheter 12. The catheter 12 mayinclude a flexible material having sufficient rigidity, strength andinner lubricity to be guided through the blood vessels to the heart andto convey the implant 10. For example, the catheter 12 may include acombination or combinations of polymeric and/or metallic materialshaving an inner diameter of between 5 French size and 50 French size, anouter diameter of between 0.004 inches 0.250 inches larger than thecorresponding inner diameter, and a length of between 10 centimeters and200 centimeters.

The guidewire 14 may be configured to be disposed within the lumen 24 ofthe catheter 12 and may have a length greater than the length of thecatheter 12. The guidewire 14 may include a flexible wire havingsufficient strength and/or rigidity to convey and/or urge the implant 10through the lumen 24 of the catheter 12. For example, the guidewire 14may include a combination or combinations of polymeric and/or metallicmaterials having a diameter of between 0.004 inches and 0.060 inches anda length of between 100 centimeters and 500 centimeters. Consistent withat least one embodiment herein, the guidewire 14 may have a diameter of1/32″.

Turning now to FIG. 2, an implant 10 consistent with at least oneembodiment of herein is illustrated. The implant 10 may comprise aspacer or valve body portion 18 (for example, a resiliently deformablespacer configured to be received in the lumen 24 of the catheter 12)which may be coupled to a shaft 20. The shaft 20 may be coupled to atleast one anchor portion/mechanism 22 configured to couple, attach,and/or otherwise secure the mitral valve implant 10 to native coronarytissue 6. According to one embodiment, at least a portion of the anchormechanism 22 may include a generally helical screw or the like 26configured to be at least partially screwed into the native coronarytissue 6.

The spacer 18 may comprise a spacer cage 28 having at least a portion ofthe outer surface 30 covered with a balloon 32. The spacer cage 28and/or the balloon 32 may comprise a resiliently flexible structureconfigured to at least partially collapse from an expanded position asillustrated to a retracted or collapsed position. When in the collapsedposition, the spacer cage 28 and balloon 32 may be configured to bereceived in and advanced along the lumen 24 of the delivery catheter 12.When in the expanded position, the spacer cage 28 and balloon 32 may beconfigured to interact and/or cooperate with at least a portion of thenative mitral valve 3 (e.g., at least one cusp 4) to reduce and/oreliminate excessive regurgitation as generally illustrated in FIG. 1.

The spacer cage 28 may comprise a frame or ribbed structure, forexample, a frame of resilient flexible material such as, but not limitedto, shape memory materials (for example, but not limited to, nickeltitanium compositions (e.g., Nitinol) or the like). The spacer cage 28may comprise a plurality of support structures or ribs 34 extendinggenerally along the longitudinal axis of the implant 10. The supportstructures 34 may be configured to resiliently bend radially inwardlyand/or outwardly, for example, to facilitate loading of the implant 10within the delivery catheter 12 and/or to facilitate sealing with themitral valve 3. The number and location of the support structures 34 maydepend upon the particulars of the patient's condition as well as thedesired flexibility and desired shape of the spacer 18. For example, theimplant 10 may comprise between 5 to 12 support structures 34.

The balloon 32 may be configured to be at least partially disposed aboutthe outer surface 30 of the spacer cage 28. The balloon 32 may comprisea resilient flexible, biologically acceptable material. For example, theballoon 32 may comprise Elasteon™ material or the like configured togenerally encapsulate the outer surface 30 of the spacer cage. Theballoon 32 may be coupled or otherwise secured to at least a portion ofone or more of the support structures 34 (for example, but not limitedto, overmolding, adhesives, and/or laminating) and/or may be onlysecured about the ends of the spacer cage 28.

The spacer 18 may therefore be configured to interact and/or cooperatewith at least a portion of the native mitral valve 3 to reduce and/oreliminate excessive regurgitation. As such, the configuration and/orgeometries of the spacer 18 may depend upon the particulars of thecondition of the patient's mitral valve 3 and the damage thereto. Theimplant 10 may have sufficient overall flexibility to facilitateadvancement of the implant 10 within the delivery catheter 12 tominimize the potential of the implant 10 becoming wedged or stuck withinthe delivery catheter 12. In addition, the implant 10 may also havesufficient overall rigidity to maintain the spacer 18 within the mitralvalve 3 such that the implant 10 performs as intended.

The spacer 18 may optionally include a garage 36 configured to couplethe spacer 18 to the shaft or stop tube 20. Consistent with at least oneembodiment herein, the support structures 34 of the spacer cage 28 maybe coupled to the garage 36, for example, about a first end region 38 ofthe garage 36. A proximal end region 40 of the stop tube 20 may becoupled to a second end region 42 of the garage 36 generally oppositethe first end region 38. The distal end region 44 of the stop tube 20may be coupled to a can 46 configured to receive at least a portion ofan anchoring device 47, for example, the helical screw 26. A portion ofthe can 46 (for example, but not limited to, the distal end region) mayinclude a sheath or pledget 48 configured to stimulate ingrowth of thenative coronary tissue 6 over time and to further anchor or secure theimplant 10 to the tissue. The garage 36 may also define a cavity 50configured to engage with the deployment mechanism 16 as describedherein.

Turning now to FIGS. 3 and 4, a cross-sectional view of an implant 10 isgenerally illustrated including a deployment mechanism 16. As will beexplained in greater detail herein, the deployment mechanism 16 isconfigured to be releasably coupled to the implant 10 such that theimplant 10 may be advanced through the delivery catheter 12 and securedto the native coronary tissue 6 of the patient's heart 1 (for example,the wall of the left ventricle 5 proximate the apex). According to atleast one embodiment, the deployment mechanism 16 may be configured toadvance the implant 10 through the delivery catheter 12 to the implantsite, rotate the implant 10 to secure the anchoring mechanism 22 to thetissue, and release the implant 10.

The deployment mechanism 16 may comprise a sleeve 52 configured toreleasably engage a latching mechanism 54. The sleeve 52 may comprise agenerally flexible tubing such as, but not limited to, apoly(tetrafluoroethylene) (PTFE) tube defining an lumen or passageway56. The sleeve 52 may be configured to be disposed within the lumen 24of the delivery catheter 12 and extend from within the implant 10 (forexample, but not limited to, from the spacer 18 and/or the garage 36)and out beyond the proximal end of the delivery catheter 12. The sleeve52 may also have an outer surface having a size and/or shape configuredto be received within the chamber or cavity 58 of the garage 36. Forexample, the sleeve 52 may have an outer configuration configured toengage the garage cavity 58 and to provide rotational and/or lateralstability of the sleeve 52 and/or the latching mechanism 54 as isdiscussed further herein. According to at least one embodimentconsistent herein, the sleeve 52 and the cavity 58 of the garage 36 mayhave a generally cylindrical configuration; however, the sleeve 52and/or the cavity 58 may have other shapes configured to providerotational and/or lateral stability of the sleeve 52 and/or the latchingmechanism 54. For example, the sleeve 52 and/or the cavity 58 may have anon-circular cross-section such as, but not limited to, a rectangular,triangular or hexagonal shape or the like.

The latching mechanism 54 may comprise a first latch pin 60 configuredto cooperate with a second latch pin 62 to form a releasable connection.The first latch pin 60 may be coupled to a delivery wire 64 configuredto be received within the lumen 56 of the sleeve 52 and to extend beyondthe distal end of the sleeve 52.

The second latch pin 62 may be coupled to a portion of the implant 10such as, but not limited to, the spacer 18, stop tube 20, and/or theanchoring mechanism 22. For example, the second latch pin 62 may becoupled to a first end region of an anchoring wire 66. The anchoringwire 66 may extend through a lumen or passageway 68 of the stop tube 20and a second end region may be coupled to the anchoring mechanism 22,for example, the helical screw 26. Optionally, one or more centeringinserts 70 may be provided along the length of the anchoring wire 66.For example, one or more inserts 70 may be provided within the can 46and/or the stop tube 20. The inserts 70 may include anopening/passageway configured to receive the anchor wire 66 to keep theanchor wire 66 centered with respect to the implant 10 and minimizebuckling and/or kinking of the anchor wire 66 during the deployment ofthe implant 10. The inserts 70 may be integrally formed with or aseparate element from the can 46 or stop tube 20.

Turning now to FIGS. 5 and 6, one embodiment of the first and secondlatch pins 60, 62 is illustrated in an uncoupled and coupled position,respectively. The first and second latch pins 60, 62 may each have agenerally “C” shaped engagement potion 72 a, 72 b. At least one of theengagement portions 72 a, 72 b may define a cavity or recess 74configured to receive a tab or protrusion 76 of the other engagementportion 72 a, 72 b as generally illustrated in FIG. 6. The engagementportions 72 a, 72 b may also have a variety of other configurationsconfigured to form a connection.

The first and second latch pins 60, 62 of the latching mechanism 54 maybe held in place in the coupled position by the sleeve 52 as generallyillustrated in FIGS. 3, 4 and 7. For example, the sleeve 52 and thefirst and second latch pins 60, 62 may have a size and/or shapeconfigured to substantially prevent the first and second latch pins 60,62 from moving relative to one another and to provide rotational and/orlateral stability when the latching mechanism is received within thesleeve. To decouple the latching mechanism 54, the sleeve 52 may bepulled back (i.e., pulled proximally away from the heart) to expose oneor more of the first and second latch pins 60, 62. Once at least one ofthe first and second latch pins 60, 62 is exposed, the delivery wire 64may be moved (for example, twisted/rotated or the like) to decouple thefirst and second latch pins 60, 62.

As discussed above, the anchoring mechanism 22 of the implant 10 mayalso include a helical screw 26 coupled to the anchoring wire 66 and astop mechanism 78. The helical screw 26 may be configured to be advancedfrom a retracted position in which the helical screw 26 is substantiallydisposed entirely within the can 46 as generally illustrated in FIG. 7to an extended position in which the helical screw 26 is configured toengage the heart tissue as generally illustrated in FIG. 8. The implant10 may be advanced through the delivery catheter 12 while in theretracted position. Retracting the helical screw 26 within the can 46while advancing the implant 10 through the delivery catheter 12 mayfacilitate loading and/or advancing the implant 10 through the deliverycatheter 12 by minimizing the likelihood that the anchoring mechanism 22may become jammed within the lumen 24 of the delivery catheter 12.Alternatively, a portion of the helical screw 26 (for example, thedistal most end region) may be disposed beyond the can 46.

The stop mechanism 78 may be configured to control the maximum depththat the helical screw 26 may be extended from the can 46 therebycontrolling the maximum depth that the helical screw 26 may be insertedinto the native coronary tissue 6 when securing the implant 10.Consistent with at least one embodiment herein, the stop mechanism 78may comprise a threaded region 80 disposed within the can 46 of theanchoring mechanism 22. The threaded region may 80 may have a threadpitch and size substantially corresponding to a first portion 82 of thehelical screw 26. As such, the first portion 82 of the helical screw 26may be rotated and threaded through the threaded region 82 of the stopmechanism 78 to advance the helical screw 26 out of the can 46 from theretracted position (as generally illustrated in FIG. 7) to the extendedposition (as generally illustrated in FIG. 8).

The helical screw 26 may also include a second portion 84 having a pitch(for example, but not limited to, a zero pitch) which cannot passthrough the threaded region 80. As the anchoring wire 66 is rotated(e.g., from a rotational torque applied to the delivery wire 64 andtransmitted through the latching mechanism 54), the first region 82 ofthe helical screw 26 may be threaded through the stop mechanism 78 untilthe second region 84 engages (e.g., binds against) the threaded region80 of the stop mechanism 78. As such, the stop mechanism 78 may beconfigured to control the maximum depth that the helical screw 26 may beextended from the can 46 thereby controlling the maximum depth that thehelical screw 26 may be inserted into the native coronary tissue 6 whensecuring the implant 10 in the heart 2.

To deliver the implant 10, the first and second latch pins 60, 62 of thelatching mechanism 54 may be coupled together as generally illustratedin FIG. 6 and loaded into the distal end region of the sleeve 52 asgenerally illustrated in FIG. 7. The sleeve 52 may be configured to keepthe first and second latch pins 60, 62 of the latching mechanism 54secured together by generally preventing movement of the first andsecond latch pins 60, 62 relative to each other. The distal end regionof the sleeve 52 (including the first and second latch pins 60, 62) maythen be received into the implant 10, for example, into the cavityformed by the garage 36 as generally illustrated in FIGS. 3 and 4. Thearrangement/configuration of the garage 36 and the sleeve 52 may providerotational stability to the first and second latch pins 60, 62 of thelatching mechanism 54 when a force or torque is applied to the deliverywire 64.

With distal end of the sleeve 52 and the first and second latch pins 60,62 of the latching mechanism 54 disposed within the can 36 as generallyillustrated in FIGS. 3 and 4, the implant 10 may be loaded into andadvanced through the delivery catheter 12 by using a pusher (forexample, but not limited to, a low density polyethylene tube or thelike). The pusher may be received into the delivery catheter 12 afterthe implant 10 and may urge the implant 10 through the delivery catheter12.

The implant 10 may be advanced through the delivery catheter 12 untilthe anchoring mechanism 22 of the implant 10 is disposed proximate thedistal end region of the delivery catheter 12 as generally illustratedFIG. 7. As the implant 10 is advanced through the delivery catheter 12,the sleeve 52 may be maintained around the latching mechanism 54 toensure that the latching mechanism 54 remains coupled. Additionally, thedimensional tolerances between the garage cavity 58 and the sleeve 52 aswell as the latching mechanism 54 and the sleeve 52 may increase therotational and/or lateral stability of the latching mechanism 54. Oncethe anchoring mechanism 22 is disposed proximate the distal end regionof the delivery catheter 12 and the delivery catheter 12 is in theappropriate location within the heart 1 (for example, but not limitedto, proximate the apex of the left ventricle 5), a translational forcemay be applied to the pusher to urge the anchoring mechanism 22 of theimplant 10 (e.g., but not limited to, the can 46) against the nativecoronary tissue 6 in the heart 1.

A torque may also be applied to the delivery wire 64 and transmittedthrough the latching mechanism 54 and the anchoring wire 66 causing thehelical screw 26 to rotate within the stop mechanism 78 as generallyillustrated FIG. 7. The delivery wire 64 may have sufficient flexibilityto pass through the delivery catheter 12 while also having sufficientrigidity to resist buckling or kinking under load. According to oneembodiment, the delivery wire 64 may include a 1/32″ wire. Thetranslational force applied to the pusher may urge the can 46 againstthe native coronary tissue 6. As a result, the torque applied to thedelivery wire 64 and anchor wire 66 may cause the helical screw 26 ofthe anchoring mechanism 22 to rotate with respect to the can 46 whilekeeping the can 46 (and the remainder of the implant 10) substantiallystationary.

As the anchoring mechanism 22 is rotated, the helical screw 26 may beadvanced from the retracted position to the extended position in whichat least a portion of the helical screw 26 is exposed beyond the distalend of the can 46 as generally illustrated in FIG. 8. The dimensionaltolerances between the garage cavity 58 and the sleeve 52 as well as thelatching mechanism 54 and the sleeve lumen 56 may increase therotational and/or lateral stability of the latching mechanism 54.Additionally, the centering inserts 70 may increase the rotationaland/or lateral stability of the anchoring wire 66 within the implant 10during rotation of the helical screw 26. The helical screw 26 may bethreaded into the tissue of the heart until the second region 84 of thehelical screw 26 engages against (e.g., binds) the stop mechanism 78.The stop mechanism 78 may therefore control the maximum depth that thehelical screw 26 may be threaded into the native coronary tissue 6 andmay reduce the potential of the helical screw 26 puncturing through theopposite side of the heart 1. Additional long-term fixation of theimplant 10 may be provided by the pledget 48 disposed about the distalend region of the anchoring mechanism 22.

Once the helical screw 26 of the implant 10 is secured to the nativecoronary tissue 6, the distal end region of the sleeve 52 may be pulledback (i.e., towards the proximal end of the delivery catheter 12) toexpose one or more of the latching pins 60, 62. Once exposed, thedelivery wire 64 may be rotated to decouple the latching pins 60, 62 andtherefore decouple the delivery wire 64 from the implant 10. Thedelivery wire 64 (along with the first latching pin 60) may then bepulled back and removed from the implant 10.

Turning now to FIGS. 9-14, one embodiment of a loading system 90 forloading an implant 10 into the delivery catheter 12 is generallyillustrated. As discussed herein, the implant 10 may include a spacer 18having a diameter which, when expanded, is greater than the diameter ofthe delivery catheter lumen 24. The loading system 90 may include aloading sheath 92, as generally illustrated in FIG. 9, configured toload the implant 10 into the delivery catheter 12. The loading sheath 92may include a distal end 93, a proximal end 94 and a hollow shaft orlumen 96. The at least a portion of the implant spacer 18 may bereceived into the hollow shaft/lumen 96 of the loading sheath 92 asgenerally illustrated in FIG. 10. The internal dimensions of the lumenloading sheath 96 may be configured to at least partially compressand/or collapse the spacer 18, thereby reducing the cross-section of theimplant 10.

Optionally, the lumen 96 of the loading sheath 92 may be configured toreceive the entire implant 10 as illustrated. For example, the anchorportion 22 of the implant 10 may be located proximate the distal end 93of the loading sheath 92. The proximal end 94 of the loading sheath 92may also be configured receive a portion of a pusher 98, for example,the proximal end region 99 of the pusher 98. As discussed herein, thepusher 98 may be configured to advance the implant 10 through thedelivery catheter to the implant 10 site and may include a low densitypolyethylene tube or the like. The delivery wire 64 may also be disposedwithin the loading sheath 92 and through the lumen of the pusher 98.

Turning now to FIG. 11, with the implant 10 and pusher 98 received inthe lumen 96 of the loading sheath 92, the distal end 93 of the loadingsheath 92 may be first advanced through the hemostasis valve 100 of thedelivery catheter 12 and optionally into the control handle 101 of thedelivery catheter 12 (which is configured to control the position of thedistal end of the delivery catheter 12) as generally illustrated in FIG.12. The loading sheath 92 may be further advanced into the deliverycatheter 12 until the entire spacer 18 is received in the deliverycatheter 12. Optionally, the loading sheath 92 may be advanced until theproximal end region 94 of the loading sheath 92 is received in thedelivery catheter 12. As such, the distal end region of the pusher 98may also be loaded into the delivery catheter 12 as well the implant 10.

With the implant 10 received within the delivery catheter 12, theloading sheath 92 may be removed from the delivery catheter 12 as wellas the implant 10 and the pusher 98. According to one embodiment, thepusher 98 may be held in place and the loading sheath 92 may be pulleddistally out of the hemostatsis valve 100 and away from the deliverycatheter 12. The loading sheath 92 may then be advanced over theremaining length of the exposed pusher 98. As may be appreciated,however, the pusher 98 may relatively long and other objects of thepercutaneous delivery system 1 may prevent the loading sheath 92 fromsimply sliding off.

To facilitate the removal of the loading sheath 92, the loading sheath92 may optionally include a peel-away sheath as generally illustrated inFIGS. 9, 10 and 13. According to this embodiment, the loading sheath 92may include a longitudinal split, perforation, or the like 102 andoptionally one or more (for example, two) tabs 103 a, 103 b and/or knobs104 a and 104 b. Once the implant 10 and/or the pusher 98 are receivedinside the lumen of the delivery catheter 12, the loading sheath 92 maybe removed by holding the pusher 98 substantially stationary and pullingon the two knobs 104 a, 104 b attached to the tabs 103 a, 103 b of theloading sheath 92 causing the loading sheath 92 to split in half alongits longitudinal axis. With the loading sheath 92 split, it may beeasily removed from the pusher 98. As a result, the implant 10 and thepusher 98 may be loaded into the delivery catheter 12 as generallyillustrated in FIG. 14.

Turning now to FIG. 15, one embodiment of a de-airing system 106 isgenerally illustrated. The de-airing system 106 is configured to allowthe user (e.g., physician) to remove any air associated with the implant10 prior to inserting the implant 10 into the delivery catheter 12. Ifentrapped air from the percutaneous delivery system is allowed to beintroduced into the patient's cardiovascular system, the air may betravel to the patient's brain or other parts of the patient's body whereit may cause serious bodily harm and/or death (for example, due to bloodclotting or the like).

According to at least one embodiment herein, the de-airing system 106may include a fluid (such as, but not limited to, a saline solution orthe like) which may be injected around the implant 10 to flush awayand/or remove any entrapped air before the implant 10 is inserted intothe delivery catheter 12. The de-airing system 106 may include a firstreservoir 108 of fluid which may be configured to be fluidly coupled tothe lumen 56 of the sleeve 52, for example, about the proximal end 109of the sleeve 52. The sleeve 52 may be disposed within a lumen 110 ofthe pusher 98 which may be substantially abutting against a distal endof the implant 10. The fluid may be injected into the lumen 56 of thesleeve 52 where it may flow through the sleeve 52 and around deliverywire 64 and the latching mechanism 54. A portion of the fluid may alsoflow pass the latching mechanism 54, through the garage 36 and stop tube20, around anchor wire 66, into the can 46 and through the threadedregion 80 and helical screw 26, and out the distal end of the implant10.

The sleeve 52 may also include one or more openings, slots, apertures112 or the like configured allow some of the fluid to pass out of thesleeve 52 and fill spacer 18. The fluid may then flow from the spacer 18into the lumen 110 of the pusher 98 back to a second reservoir 114fluidly coupled to the pusher 98. As may be appreciated, the fluidflowing through the de-airing system 106 may remove any air entrappedaround the implant 10. As a result, the implant 10 may be loaded intothe delivery catheter 12 without introducing any unwanted air into thepatient's cardiovascular system.

Turning now to FIG. 16, one embodiment of a de-airing driver handlesystem 116 is illustrated in an exploded or unassembled view. Thede-airing driver handle system 116 may include a de-airing system and/ora driver handle. The de-airing system may be configured to remove airfrom the implant 10 prior to inserting the implant 10 into the deliverycatheter 12 as discussed herein while the driver handle may beconfigured to manage the position of the sleeve 52 and decoupling of thelatching mechanism 54 as well as to enable rotation of the helical screw26 into the native coronary tissue 6 upon deployment of the implant 10.

The de-airing driver handle system 116 may include a pusher fitting 120configured to terminate the proximal end of the pusher 98. The pusherfitting 120 may be configured to allow the sleeve 52 to be disposedwithin the lumen 110 of the pusher 98 and to extend beyond the proximalend of the pusher 98. For example, the pusher fitting 120 may acompression fitting or the like. A fluid receiving reservoir 122 may befluidly coupled to the pusher fitting 120 and may be configured toreceive fluid flowing from the implant 10 and the pusher lumen 110.According to at least one embodiment, the fluid receiving reservoir 122may include a fitting including a needle-less injector port 123 or thelike.

A sleeve fitting 124 may also be coupled to the fluid receivingreservoir 122 for terminating the proximal end of the sleeve 52. Thesleeve fitting 124 may be configured to allow the delivery wire 64 to bedisposed within the lumen 56 of the sleeve 52 and to extend beyond theproximal end of the sleeve 52. For example, the sleeve fitting 124 mayinclude a compression fitting or the like. A fluid injection reservoir126 may be fluidly coupled to the sleeve fitting 124 and may beconfigured to inject fluid into lumen 54 of the sleeve 52 where itultimately flows around the implant 10 and into the pusher 98 asdiscussed herein. According to at least one embodiment, the fluidinjection reservoir 126 may include a fitting configured to be fluidlycoupled to a syringe 128 or the like and the sleeve 52. The fitting maybe configured to allow the delivery wire 64 to sealingly pass through.Optionally, a valve 130 (such as, but not limited to, a stopcock or thelike) may be provided to further regulate the flow of fluid form thefluid injection reservoir 126. A drive knob 132 or the like may becoupled to the delivery wire 64 to rotate the delivery wire 64 and,ultimately, the helical screw 26 of the anchor mechanism 22. The driveknob 132 may include a set-screw, clamp or the like 134 configured toallow the drive knob 132 to be releasably coupled to the delivery wire64.

It may be appreciated that one embodiment of the functional componentsof the de-airing driver handle system 116 have been illustrated anddescribed. The various components may be combined and/or split into oneor more systems. For example, the various fittings may be combined intoa single driver handle device to facilitate their use.

Turning now to FIGS. 17-22, one embodiment illustrating the procedurefor anchoring the implant 10 into the native coronary tissue 6 isgenerally illustrated. The implant 10 may be advanced through thedelivery catheter 12 by applying a translational force to the pusher 98and against the implant 10. As the implant 10 along with the entirepusher 98 assembly (de-airing driver handle system 116) is advancedforward through the delivery catheter 12, the can 46 of the implant 10may emerge from the distal end of the delivery catheter 12 and may beurged/biased against the native coronary tissue 6 (for example, againstthe wall of the left ventricle 5 proximate the apex) as generallyillustrated in FIGS. 1 and 17. As can be seen, the distal end region ofthe sleeve 52 may be disposed substantially around the latchingmechanism 54 including the first and second latching pins 60, 62. Inaddition, the anchoring mechanism 22 may be disposed in the retractedposition in which the helical screw 26 may be disposed within the can46.

Turning now to FIG. 18, the set-screw 134 on the driver knob 132 mayoptionally be loosened and the drive knob 132 may be moved back from theproximal end of the de-airing handle system 116 along the delivery wire64 and retightened to allow the helical screw 26 to be advanced duringthe subsequent steps. For example, the drive knob 132 may be moved backapproximately 1 cm.

With the can 46 against the native coronary tissue 6 and the driver knob132 moved back from the de-airing handle system 116, the driver knob 132may be rotated and urged forward to cause the delivery wire 64 to berotated as generally illustrated in FIG. 19. The torque may betransmitted through the latching mechanism 54 causing the anchoring wire66 and ultimate the helical screw 26 to rotate. Additionally, atranslational force may be applied to the pusher 98 to urge the can 46of the implant 10 against the native coronary tissue 6 and generallyprevent rotation of the can 46. The sleeve 52 may be disposed about thefirst and second latching pins 60, 62 and, along with the garage 36, maybe configured to provide lateral and rotational stability to thelatching mechanism 54 as described herein. Additionally, one or morecentering inserts 70 may also provide additional lateral and rotationalstability.

The first portion 82 of the helical screw 26 may rotate within thethreaded region 80 to advance the helical screw 26 beyond the distal endof the can 46 and into the native coronary tissue 6. The helical screw26 may be advanced beyond the distal end of the can 46 until the secondportion engages 84 against or binds with the threaded region 80. As aresult, the maximum depth that the helical screw 26 may be advanced intothe native coronary tissue 6 may be controlled and puncturing of theheart wall 1 may be avoided.

Turning now to FIG. 20, the set-screw 134 on the driver knob 132 mayoptionally be loosened and the drive knob 132 may be moved back from theproximal end of the de-airing handle system 116 along the delivery wire64 and retightened to allow the latching mechanism 54 to be decoupled.For example, the drive knob 132 may be moved back approximately 2inches.

To decouple the latching mechanism 54, the sleeve 52 fitting of thede-airing handle system 116 may be disconnected and the sleeve 52 may beretracted (i.e., moved proximally away from the implant 10) as generallyillustrated in FIG. 21. As the sleeve 52 is retracted, one or more ofthe latching pins 60, 62 may be exposed from the distal end region ofthe sleeve 52. The latching pins 60, 62 may still be loosely coupled atthis point.

Turning now to FIG. 22, the delivery wire 64 may also be retracted.Retracting the delivery wire 64 may fully disengage/decouple the firstand second latching pins 60, 62. The disengagement of the latchingmechanism 54 may be seen on fluoroscopy or the like and may also be feltby the physician (the delivery wire 64 will feel loose whendisengaged/decoupled). The sleeve 52 and the delivery wire 64 may beretracted out of the implant 10 (not shown). The pusher 98 may be heldagainst the implant 10 and the delivery catheter 12 may be retracted tofurther deploy the implant 10.

As mentioned above, the present disclosure is not intended to be limitedto a system or method which must satisfy one or more of any stated orimplied object or feature of the present disclosure and should not belimited to the preferred, exemplary, or primary embodiment(s) describedherein. The foregoing description of a preferred embodiment of thepresent disclosure has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit the presentdisclosure to the precise form disclosed. Obvious modifications orvariations are possible in light of the above teachings. The embodimentwas chosen and described to provide the best illustration of theprinciples of the present disclosure and its practical application tothereby enable one of ordinary skill in the art to utilize the presentdisclosure in various embodiments and with various modifications as issuited to the particular use contemplated. All such modifications andvariations are within the scope of the present disclosure as determinedby the claims when interpreted in accordance with breadth to which theyare fairly, legally and equitably entitled.

1. An implant delivery system comprising: a catheter including at leastone lumen; an implant configured to be received in said lumen; and alatching mechanism configured to be received in said implant, saidlatching mechanism further configured to releasably couple said implantto a delivery wire and to transmit a torque through said delivery wireto cause at least a portion of said implant to rotate.
 2. The implantdelivery system of claim 1, wherein said implant comprises a shaft, aspacer configured to interact with at least a portion of at least onecusp of a heart valve to at least partially restrict a flow of bloodthrough said heart valve in a closed position, at least one anchormechanism coupled to a first end region of said shaft.
 3. The implantdelivery system of claim 2, wherein said latching mechanism comprises afirst and at least a second latch pin configured to engage with eachother to form a connection, wherein said first latching pin is coupledto said delivery wire and said second latching pin is configured to becoupled to said implant.
 4. The implant delivery system of claim 3,further comprising a sleeve defining lumen having a distal end regionconfigured to receive at least a portion of said delivery wire and saidfirst and said second latching pins.
 5. The implant delivery system ofclaim 4, wherein said lumen of said sleeve is further to substantiallyprevent movement of said first latching pin relative to said secondlatching pin when said first and said second latching pins are receivedin said distal end region.
 6. The implant delivery system of claim 5,wherein said implant further comprises garage configured to couple saidspacer to said shaft, said garage defining a cavity configured toreceive said distal end region of said sleeve to increase rotational andtranslational stability of said sleeve.
 7. The implant delivery systemof claim 6, wherein sleeve is configured to be retracted to expose atleast one of said latching pins from said distal end region and todecouple said first latching pin from said second latching pin.
 8. Theimplant delivery system of claim 5, wherein said distal end region ofsaid sleeve further comprises at least one opening configured to providea passageway between said lumen of said sleeve and said spacer of saidimplant.
 9. The implant delivery system of claim 5, further comprisingan anchoring having a first end coupled to said second latching pin anda second end coupled to said anchoring mechanism.
 10. The implantdelivery system of claim 9, wherein said anchoring mechanism comprises acavity configured to at least partially receive a helical screw.
 11. Theimplant delivery system of claim 10, wherein said anchoring mechanismfurther comprises a threaded region secured within said cavity, saidthreaded region having a thread pitch and size substantiallycorresponding to a first threaded region of said helical screw.
 12. Theimplant delivery system of claim 11, wherein said helical screw furthercomprises a second threaded region disposed proximate said anchoringwire, said second threaded region configured to not pass through saidthreaded insert.
 13. An implant comprising: a shaft; a spacer configuredto interact with at least a portion of at least one cusp of a heartvalve to at least partially restrict a flow of blood through said heartvalve in a closed position; a garage configured to couple said spacer toa first end region of said shaft, said garage defining a cavityconfigured to receive a latching mechanism and to increase rotationaland translational stability of said latching mechanism; and at least oneanchor mechanism coupled to a second end region of said shaft.
 14. Theimplant of claim 13, wherein said anchor mechanism comprises a cavityconfigured to at least partially receive a helical screw, said helicalscrew coupled to a first end of an anchoring wire, wherein a second endof said helical screw is coupled to a latching pin configured to bereceived in said cavity of said garage.
 15. The implant of claim 14,wherein said anchoring mechanism further comprises a threaded regionsecured within said cavity, said threaded region having a thread pitchand size substantially corresponding to a first threaded region of saidhelical screw.
 16. The implant of claim 15, wherein said helical screwfurther comprises a second threaded region disposed proximate saidanchoring wire, said second threaded region configured to not passthrough said threaded insert.
 17. The implant of claim 13, wherein saidanchoring mechanism further comprises a pledget configured to stimulateingrowth of tissue.
 18. A method of delivering an implant within aheart, said implant including a shaft, a spacer configured to interactwith at least a portion of at least one cusp of a heart valve to atleast partially restrict a flow of blood through said heart valve in aclosed position, and at least one anchor mechanism coupled to a firstend region of said shaft, said method comprising. providing a deliverywire having a first latch pin; coupling said first latch pin to a secondlatch pin disposed within said implant; advancing a distal end of asleeve over said first and said second latch pins to prevent movement ofsaid first and said second latch pins; percutaneously delivering acatheter proximate said heart; loading said implant and said distal endof said sleeve into said catheter; and advancing said implant and saiddistal end of said sleeve through said catheter.
 19. The method of claim18, further comprising rotating said delivery wire and transmittingtorque through said first and said second pins to cause said anchoringmechanism to engage tissue within said heart.
 20. The method of claim19, further comprising: retracting said distal end of said sleeve toexpose at least one of said first and second pins; and decoupling saidfirst and said second latching pins.